Role Objective:

- A key objective of this role is to lead end-to-end site operations for a sterile manufacturing facility.

- The role is responsible for driving operational excellence across Quality, Delivery, Cost and Continuous -Improvement, while ensuring strong regulatory compliance and building a high-performance manufacturing culture.

- This position plays a critical role in strengthening operational readiness, supporting business growth, and ensuring consistent delivery in a regulated pharmaceutical environment.

Desired Candidate Profile:

- Education: Master's degree in Science / Pharmaceutical Sciences / related discipline preferred.

- Advanced certifications in manufacturing, quality, and Lean/Six Sigma are advantageous.

- Experience: 15-20 years of progressive experience in pharmaceutical manufacturing with strong leadership exposure, including site-level ownership.

Mandatory Leadership Fit (Must-Have):

- Must have been a Site Lead / Plant Head / Unit Head with end-to-end accountability (manufacturing, compliance readiness, delivery, cost, people).

- Demonstrated track record of driving QDCI rigorously and improving plant performance with measurable outcomes.

- Strong understanding and execution of OTIF metrics and delivery excellence.

Regulatory & Compliance (Must-Have):

- Strong hands-on experience in USFDA-regulated/USFDA-inspected plants, including audit preparedness and remediation/quality maturity.

- Working knowledge of cGMP and relevant global standards like MHRA, ANVISA, etc.

Technical Domain (Must-Have):

- Proven exposure to Sterile Injectables manufacturing, with preference for Prefilled Syringes (PFS) or closely related formats.

Financial & Business Acumen (Must-Have):

- Full grip on budgeting, costings, COGS/COGM control, and productivity/capacity utilization.

- Ability to align manufacturing performance with business and financial goals.

Mindset & Growth Orientation:

- High ownership, a "hungry to grow" attitude, high energy, and strong execution bias.

Role Requirements:

- Lead and oversee end-to-end manufacturing operations for the site, ensuring alignment with business objectives.

- Drive site performance across Quality, Delivery, Cost, and Continuous Improvement (QDCI).

- Ensure robust regulatory compliance and continuous inspection readiness for global regulatory agencies.

- Own delivery performance, ensuring On-Time-In-Full (OTIF) adherence and schedule reliability.

- Lead annual operating plans, budgets, and productivity initiatives to improve cost efficiency and capacity utilization.

- Strengthen manufacturing systems to ensure right-first-time execution, effective deviation/CAPA management, and audit readiness.

- Identify operational risks and implement contingency plans to ensure business continuity.

- Drive process improvements, automation, and technology adoption, especially within sterile manufacturing operations.

- Collaborate closely with cross-functional teams including Quality, Supply Chain, Engineering, Finance, EHS, and HR.

- Lead, mentor, and develop senior manufacturing leaders and build a strong succession pipeline.

- Take charge during critical operational situations, ensuring structured problem-solving and sustainable corrective actions.

Functional Skills:

- Manufacturing Operations Management (Sterile / Injectables / PFS preferred).

- Strong QDCI execution and governance.

- Strong OTIF ownership and delivery excellence.

- Quality Management Systems & cGMP compliance.

- USFDA audit readiness and inspection handling.

- Strategic planning, capacity planning, and execution excellence.

- Budgeting, Costing, COGS/COGM control, productivity improvement.

- Process automation / technology adoption / Lean / CI.